Role Summary

The Manager, U.S. Trade & Distribution serves as the Functional Subject Matter Expert (SME) and US DSCSA Key User. Reporting to the Senior Director, U.S. Trade & Distribution, this role is the primary point of contact for DSCSA-related systems and compliance. You are responsible for ensuring Right of Sale by maintaining serialization integrity, system interoperability, and Authorized Trading Partner (ATP) governance. This individual ensures that every unit of product is fully traceable and that inventory levels across the 3PL and wholesale network are optimized to prevent stock-outs or over-supply.

Job Description

Primary Responsibilities

1. DSCSA Compliance and Right of Sale Governance

• Serve as the primary business process owner for DSCSA compliance, managing transaction statements (T3), serialization data exchange (EPCIS), and interoperable traceability systems (TraceLink)
• Maintain an up-to-date understanding of DSCSA interoperability requirements and translate them into internal standard operating procedures (SOPs)
• Manage the Verification Router Service (VRS) requirements and oversee the governance of saleable returns to ensure compliance with federal verification mandates

1. System Architecture & Digital Transformation

• Lead User Acceptance Testing (UAT) for DSCSA system upgrades, partner connectivity projects, and the adoption of cloud-based serialization tools
• Work closely with the Serialization Central Team at Servier LLS (France) for system setup assistance and global data alignment
• Provide oversight for EPCIS data exchanges to ensure serialization data sharing remains compliant with internal security protocols and data privacy requirements

1. Investigation, Audit & Inspection Readiness

• Serve as the primary Subject Matter Expert for FDA inspections regarding U.S. product traceability
• Collaborate with global partners for investigations into suspect or illegitimate products.
• Lead local investigations into data mismatches, and serialization exception reports, driving corrective and preventive actions (CAPA)
• Coordinate with Regulatory, Legal, and Quality to vet and document the ATP status of all partners in the supply chain

1. Trade Forecasting & Inventory Management

• Develop and maintain trade-related demand models, integrating wholesaler data (852/867) to provide an accurate view of channel inventory & needs
• Partner with Business Analytics & Insights, Supply Chain and Finance to lead the Monthly S&OP (Sales and Operations Planning) process for Trade
• Provide monthly updates on 3-year forecasted demand via Kinaxis planning management tool to inform Global production and supply chain planning
• Identify and mitigate risks related to product dating, potential shortages, or inventory imbalances across the distribution network
• Anticipate new product launches trade requirements, versioning & stoppage to secure on time launches or limit inventory risks

Education and Required Skills

• Education: Bachelor's degree required; MBA or advanced degree in supply chain management, healthcare administration, or Information Technology preferred
• Experience: 5+ years in pharmaceutical supply chain, trade operations, or compliance.
• Technical Expertise: Proficiency in TraceLink, EPCIS data standards, and SAP/ERP systems
• Regulatory Knowledge: Deep understanding of the DSCSA 2023 Interoperability requirements, ATP requirements, and drop-ship distribution models
• Strategic Thinking: Ability to interpret complex serialization exception reports and resolve data-sharing errors with 3PLs and wholesalers in real-time

Travel and Location

• Boston-based, reporting to the Seaport office at least 2-3 days per week
• Travel up to 20%, domestically and internationally

Candidate Profile

Salary Range

The salary range for this role is $135k-155k. An employee's pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link.